Omnipod DASH™ System Receives FDA Clearance

We will be conducting a six-month, limited market release of the Omnipod DASH™ System in the United States. The commercial release of the Omnipod DASH™ System is anticipated for early 2019.

Here are the answers to the most frequently asked questions surrounding the Omnipod DASH™ System:

Questions About The System

What is the Omnipod DASH™ Insulin Management System?

The Omnipod DASH™ Insulin Management System is a tubeless, wearable insulin pump that holds up to 200 units of insulin and delivers continuous insulin therapy through customizable basal rates and bolus amounts. The system consists of the Pod, which is a waterproof* insulin pump worn on-body, and the Personal Diabetes Manager (PDM), which is a handheld device used to wirelessly control the Pod. The PDM has a modern, touch-screen interface that is simple, colorful and intuitive.

With Bluetooth® wireless technology, the Omnipod DASH™ System will also feature a suite of mobile applications that will allow users quick and easy access to their PDM data on their smartphone and the ability to share therapy status information with up to 12 friends or family members. The Omnipod DASH™ System will have the Today View Widget which will give users the ability to see their CGM and insulin delivery information together on a single screen on their personal iOS mobile devices, helping to make diabetes management simple and seamless.

The Omnipod DASH™ System includes the following features:

Discreet, tubeless, waterproof* Pod

Customizable basal insulin profile and bolus calculator

Intuitive graphical displays

CalorieKing® food library with carbohydrate content for up to 80,000 foods

Rechargeable lithium ion battery

Optimized for use with the highly accurate** CONTOUR®NEXT ONE Blood Glucose Meter for wireless transfer of blood glucose readings to the DASH™ PDM

Which blood glucose meters can be used with the Omnipod DASH™ System?

The CONTOUR®NEXT ONE Blood Glucose Meter from Ascensia Diabetes Care is the only compatible meter that will transfer blood glucose readings to the Personal Diabetes Manager (PDM) via Bluetooth® wireless technology. It will come shipped within the Omnipod DASH™ System Welcome Kit for new users.

If a patient chooses to use an alternative blood glucose (BG) meter with the Omnipod DASH™ System, it will not wirelessly transmit BG readings to the Omnipod DASH™ PDM.

What is the Omnipod DISPLAY™ app?

The Omnipod DISPLAY™ app allows for a convenient display of Personal Diabetes Manager (PDM) data on the user’s smartphone as well as a “Find My PDM” feature.

The Omnipod DISPLAY™ app is for iOS only at this time. Insulet is working on developing the Omnipod DISPLAY™ app for Android and will announce more details in the future.

What is the Omnipod VIEW™ app?

The Omnipod VIEW™ app lets up to 12 care partners view their loved one’s Omnipod DASH™ System data on their iOS smartphone remotely.

The Omnipod VIEW™ app is for iOS devices only at this time. Insulet is working on developing the Omnipod VIEW™ app for Android and will announce more details in the future.

Will current Pods work with the new Omnipod DASH™ System?

No, the current Pods will not be compatible with the Omnipod DASH™ System.

Omnipod DASH™ Pods have a blue needle cap and updated Pod label for differentiation. In addition, the current Omnipod® PDM will not be compatible with Omnipod DASH™ System Pods.

Does the Omnipod DASH™ Personal Diabetes Manager (PDM) integrate with a Continuous Glucose Monitoring System (CGM)?

No. At this time, there are no CGMs that have integrated functionality with the Omnipod DASH™ System. However, for those who utilize the Omnipod DISPLAY™ app on their iOS smartphone, a Today View Widget will be available and can be configured alongside the Dexcom System Widget. This will provide an integrated view of both PDM and insulin data next to their Dexcom CGM data. Additionally, HCPs and patients can see their CGM and insulin data together via Insulet Provided Glooko.

Can the Omnipod DASH™ Personal Diabetes Manager (PDM) data be uploaded to a data management system?

Yes. You will be able to upload the data from your Omnipod DASH™ System to Glooko, including Insulet Provided Glooko. At full market release, you will be able to set your DASH™ PDM to automatically upload your data to Insulet Provided Glooko whenever you are connected to Wi-Fi for quick access to up-to-date information for you and your health care provider. You may also upload the Omnipod DASH™ System the way you do today.

Does the Omnipod DASH™ Pod hold more/less insulin?

The Omnipod DASH™ Pod will be able to hold up to 200 units of U-100 insulin, which is the same as the current Pod.

Does the Omnipod DASH™ allow you to program zero basal rates?

Yes, with the Omnipod DASH™ System you will be able to deliver a 0 U/hr basal rate.

Do I still have to change the DASH™ Pod every three days?

Yes. The Omnipod DASH™ System Pod will feature up to 72 hours of continuous insulin delivery.

What does Bluetooth® mean as it relates to the Omnipod DASH™ System?

Bluetooth® wireless technology enables connectivity between the DASH™ Pod and DASH™ PDM as well as to the CONTOUR®NEXT ONE Blood Glucose Meter.

Additionally, Bluetooth® wireless technology provides the capability to see Omnipod DASH™ System data on a user's iOS smartphone via a suite of mobile apps.

Is the Omnipod DASH™ Pod the same size as the current Omnipod® Pods?

Yes, the DASH™ Pod is the same size as the current Pod.

What is the size of the Omnipod DASH™ PDM?

The Omnipod DASH™ PDM has a slim, sleek design with a 4 inch screen and thickness of 1 cm (or .39 inches). The DASH™ PDM is also lightweight, weighing in at 6.17 oz.

Is the Omnipod DASH™ PDM waterproof? Is the Pod still waterproof?

The same waterproof rating as the current Pod applies for the DASH™ Pod: Up to 25 feet for 60 minutes. The DASH™ PDM is not waterproof.

Questions About Availability For New Customers

What does it mean that the Omnipod DASH™ System received “clearance”?

Insulet has received clearance from the FDA for commercialization of the Omnipod DASH™ Insulin Management System in the United States.

Full launch of the Omnipod DASH™ System is anticipated for early 2019. Please refer to our website myomnipod.com for the latest updates on availability.

Can I be part of the limited market release?

We have identified a limited number of endocrinologists who can prescribe the Omnipod DASH™ System during the limited market release in the United States. Only patients under the care of those endocrinologists and who have coverage for Omnipod DASH™ System may participate in the Omnipod DASH™ AHEAD Program.

At this time, each endocrinologist will use their clinical judgment to determine for whom they will prescribe the Omnipod DASH™ System. There will be a restricted number of patients per practice involved in the program.

When will Omnipod DASH™ be available for everyone?

We anticipate launching the Omnipod DASH™ System in early 2019. Please refer to our website myomnipod.com for the latest updates on availability.

Where do I go to find updates on the availability of the Omnipod DASH™ System?

The latest information on the availability of the Omnipod DASH™ System will be posted on myomnipod.com.

Inside Sales and Customer Care will not have any additional information other than what is found on myomnipod.com. To avoid long wait times we recommend you visit myomnipod.com. We anticipate launching the Omnipod DASH™ System in early 2019.

Can I be put on a waiting list or priority list for the Omnipod DASH™ System?

At this time, there is no prioritization or waiting list. The Omnipod DASH™ System will be available once we move into a full market release in early 2019. For any further questions, please contact Customer Care at 800-591-3455.

If a new customer is interested, what will the process be to obtain the Omnipod DASH™ System?

New customers should get started on the existing Omnipod® System as soon as possible as the same proven benefits of the Pod are available through the existing Omnipod® Insulin Management System. With the Omnipod DASH™ System, the Personal Diabetes Manager is free*** with the purchase of Pods which eliminates the majority of insurance warranty barriers.

You may place an order for the Omnipod DASH™ System now and we will coordinate the shipment at full market release. If you do not wish to order DASH™, we can update your PodderCentral™ account so you can monitor DASH™ coverage based on your insurance plan.

Are you discontinuing the existing Omnipod® Insulin Management System?

At this time the existing Omnipod® Insulin Management System will not be discontinued. You do not need to switch to the new Omnipod DASH™ System once it becomes available and may continue to use and obtain Pods as you do today with the existing Omnipod® System.

Is the Omnipod DASH™ System available in Canada and Europe?

Not at this time. The Omnipod DASH™ System is only FDA cleared.

The Omnipod® Insulin Management System will continue to be available in Canada and Europe.

*** With the Omnipod DASH™ System, customers will be eligible to receive 1 free PDM every 4 years with the purchase of Pods subject to certain conditions including but not limited to, verification of insurance.